FDA 510(k)

PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS

K-Number: K973862 · 1997-12-29

Decision Date1997-12-29

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Sims Deltec, Inc.. It received FDA 510(k) clearance on 1997-12-29 under 510(k) number K973862. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS?

PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS is a medical device that received FDA 510(k) clearance on 1997-12-29. The listed applicant is Sims Deltec, Inc.. The 510(k) number is K973862.

When did PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS receive FDA 510(k) clearance?

PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS received FDA 510(k) clearance on 1997-12-29, under 510(k) number K973862.

Who is the listed applicant for PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS?

The FDA 510(k) record lists Sims Deltec, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS?

The FDA product code for PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS is LJT.

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Other records listing Sims Deltec, Inc. as applicant

K010426PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER K000842CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM K000942CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090 K994216PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM K992697PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM K992880P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM

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Related Devices (Code: LJT)

K260916FLEXI-PORT™ Power Injectable Implantable PortPortal Access, Inc.K252478Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable PortBard Access Systems, Inc.K251253PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable PortBard Access Systems, Inc.K242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable PortsBard Access Systems, Inc.K232737PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable Port; PowerPort™ isp M.R.I.™ ECG Enabled Implantable Port; PowerPort™ Slim ECG Enabled Implantable PortBard Peripheral Vascular, Inc.K190559SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsAngioDynamics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.